Evaluation of Brain Connectivity Function in Predicting Therapeutic Effects in Patients With Refractory Constipation: a Multicenter, Prospective, Cohort Study
Overview
- Phase
- N/A
- Intervention
- BOLD-fMRI
- Conditions
- Constipation - Functional
- Sponsor
- Xijing Hospital of Digestive Diseases
- Enrollment
- 150
- Locations
- 3
- Primary Endpoint
- Brain functional connectivity changes in BOLD-fMRI examination in refractory constipation before and after fluoxetine treatment
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
The goal of this observational study is to identify the characteristics of brain functional connectivity in refractory constipation and fluoxetine-sensitive patients. The main questions it aims to answer are:
- Investigating the alterations in brain functional connectivity in patients with refractory constipation and fluoxetine-sensitive patients
- Assessing the predictive value of brain functional connectivity regarding the efficacy of fluoxetine and standard protocol treatments for constipation.
Participants will receive:
- Standard physiological and psychological assessments of constipation
- BOLD-fMRI tests
- Standard protocol and fluoxetine treatment
If there is a comparison group: Researchers will compare:
Refractory group/Fluoxetine sensitive group to see the specific brain alterations.
Investigators
Zhifeng Zhao, PhD
Dr.
Xijing Hospital of Digestive Diseases
Eligibility Criteria
Inclusion Criteria
- •18≤ age ≤ 45 years old
- •Right-handed
- •Patients diagnosed as functional constipation according to the Rome IV criteria
- •Informed consent of patients
Exclusion Criteria
- •Complicated with gastrointestinal organic disease or significant functional abnormalities (tuberculosis, polyps, Crohn's disease, tumors, congenital megacolon, pelvic floor muscle relaxation, abnormal colonic transit test, etc.)
- •Long-term intense exercise (continuous exercise for more than 8 hours per week, such as marathon runners or triathletes)
- •No history of chronic pain, no recent major trauma
- •Drug abuse or tobacco dependence (half a pack or more per day)
- •Combined hypothyroidism and Parkinson's disease
- •Patients with confirmed mental illness or neurological disorders who take psychotropic drugs, analgesics or hormones
- •History of abdominal surgery (appendectomy, hysterectomy, or cholecystectomy)
- •Contraindications to functional magnetic resonance imaging (claustrophobia, metal implants)
- •Pregnant or lactating women with constipation after delivery
- •Patients with other benign and malignant tumors and autoimmune diseases
Arms & Interventions
Refractory constipation: fluoxetine sensitive
Functional constipation patients maintained at least 3 months of continuous regular therapy with ineffective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet. After 3 months of regular treatment, patients received fluoxetine therapy for 4-week with effective treatment of constipation symptoms.
Intervention: BOLD-fMRI
Refractory constipation: fluoxetine sensitive
Functional constipation patients maintained at least 3 months of continuous regular therapy with ineffective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet. After 3 months of regular treatment, patients received fluoxetine therapy for 4-week with effective treatment of constipation symptoms.
Intervention: Regular treatment of functional constipation
Refractory constipation: fluoxetine sensitive
Functional constipation patients maintained at least 3 months of continuous regular therapy with ineffective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet. After 3 months of regular treatment, patients received fluoxetine therapy for 4-week with effective treatment of constipation symptoms.
Intervention: fluoxetine
Refractory constipation: fluoxetine insensitive
Functional constipation patients maintained at least 3 months of continuous regular therapy with ineffective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet. After 3 months of regular treatment, patients received fluoxetine therapy for 4-week with ineffective treatment of constipation symptoms.
Intervention: BOLD-fMRI
Refractory constipation: fluoxetine insensitive
Functional constipation patients maintained at least 3 months of continuous regular therapy with ineffective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet. After 3 months of regular treatment, patients received fluoxetine therapy for 4-week with ineffective treatment of constipation symptoms.
Intervention: Regular treatment of functional constipation
Refractory constipation: fluoxetine insensitive
Functional constipation patients maintained at least 3 months of continuous regular therapy with ineffective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet. After 3 months of regular treatment, patients received fluoxetine therapy for 4-week with ineffective treatment of constipation symptoms.
Intervention: fluoxetine
Non-refractory constipation
Functional constipation patients maintained at least 3 months of continuous regular therapy with effective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet.
Intervention: BOLD-fMRI
Non-refractory constipation
Functional constipation patients maintained at least 3 months of continuous regular therapy with effective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet.
Intervention: Regular treatment of functional constipation
Health Control
Volunteers without symptoms of constipation
Intervention: BOLD-fMRI
Outcomes
Primary Outcomes
Brain functional connectivity changes in BOLD-fMRI examination in refractory constipation before and after fluoxetine treatment
Time Frame: 1-week pre and 4-week post of fluoxetine treatment
BOLD-fMRI tests before and after fluoxetine treatment
Secondary Outcomes
- Changes in PAC-QOL self-assessment scores from baseline(1-week pre and 4-week post-fluoxetine treatment.)
- Changes in GAD-7 self-assessment scores from baseline.(1-week pre and 4-week post-fluoxetine treatment.)
- Changes in PHQ-15 self-assessment scores relative to baseline.(1-week pre and 4-week post-fluoxetine treatment.)
- Changes in PHQ-9 self-assessment scores since baseline.(1-week pre and 4-week post-fluoxetine treatment.)
- Changes in KESS self-assessment scores from baseline.(1-week pre and 4-week post-fluoxetine treatment.)